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Head of Quality

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

MilliporeSigma’s Stoneham manufacturing site is looking to hire a new Head of Quality for the site. The Stoneham facility is a small manufacturing center dedicated to manufacturing the unique Mobius Breez Microbioreactor. The Head of Quality will be responsible for manufacturing quality for the site and has a broad mandate to continuously work to improve manufacturing quality and work closely with site R&D to implement design improvements for the Breez product line. This role is a good opportunity for a dynamic quality engineer to take on additional responsibility with latitude to lead quality projects associated with a novel, high-performance product for the pharma industry.

 

The Head of Quality will develop and oversee the site Quality Management System. Specific duties include:

  • Ensure quality strategies and processes meet internal and external regulatory requirements, business objectives, and operational needs.
  • Drive necessary quality process changes and improvements to achieve quality goals.
  • Conduct risk assessments to enhance prevention over correction.
  • Determine and monitor quality KPIs for ongoing performance tracking.
  • Facilitate strong communication between engineering, production, and quality teams to share nonconformance information and implement improvements.
  • Conduct annual management review meetings and coordinate QMS audits.
  • Oversee and manage key quality systems processes.
  • Investigate, collect, review, and analyze quality-related data.
  • Assume ownership of site-level QMS tools and training.

Who You Are

Minimum Qualifications:

  • Bachelor’s degree in Engineering and four (4) years of experience as a Quality Engineer (or related occupation) utilizing quality systems for a manufacturing facility. 
  • Demonstrated ability performing risk assessments, process validations, and process mapping 
  • Demonstrated experience working with the following regulatory guidelines: Good Manufacturing Practices (GMP), Good Documentation practices (GDP), and 21 CFR part 11
  • Demonstrated ability performing supplier quality management in a regulated industry
  • Demonstrated ability performing or participating in quality systems
  • Demonstrated ability overseeing product batch releases

 

Preferred Qualifications:

  • Master’s degree in Engineering and two (2) years of experience as a Quality Engineer (or related occupation) utilizing quality systems for a manufacturing facility.
  • Certifications in Quality Systems Auditing (e.g., ISO 9001) and Quality Management Systems (e.g., ISO 9001:2015).


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 
Job Requisition ID:  282606
Location:  Stoneham
Career Level:  D - Professional (4-9 years)
Working time model:  Full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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Nearest Major Market: Boston
Job Segment: Quality Manager, Developer, Quality, Technology

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